Device to treat incontinence

Abstract

A skin surface electrode used in the treatment of incontinence. The electrode has one or more conductive regions and an egress through which bodily fluid may pass without substantially adversely affecting tissue contact in the conductive regions of the electrode. The electrode is configured for placement proximate a patient's perineal tissues. An incontinence treatment system includes an electrode, wearable signal generator and interface module.

What is claimed is: 
     
       1. An electrode device for use in treating incontinence in an individual or animal, comprising:
 a body having a contact side and a non-contact side, extending longitudinally between a first end and second end, and defining a medial egress from the contact side to the non-contact side; 
 two or more activatable conductors spaced from each other and positioned around the periphery of the egress on the contact side of the body and being electrically insulated from the non-contact side; wherein 
 the contact side defines a surface and profile configured for interfacing with perineal tissue in a position with the medial egress aligned and external to a ureteral or vaginal opening of the individual or animal, whereby electrical current generated through the conductors is allowed to penetrate the perineal tissue and stimulate at least one muscle therein in the individual or animal, and the medial egress allows bodily waste to be excreted from the ureteral or vaginal opening through the egress without obstruction. 
 
     
     
       2. The electrode device of  claim 1 , comprising at least three conductors. 
     
     
       3. The electrode device of  claim 1 , wherein the conductors comprise at least two cooperative anode-cathode pairs. 
     
     
       4. The electrode device of  claim 1 , wherein the body defines an outer peripheral edge that transitions inwardly toward an intermediate portion between the first and second ends. 
     
     
       5. The electrode device of  claim 1 , wherein the contact side of the body includes a non-conductive region for fluidly isolating the conductors from fluid passing through the egress. 
     
     
       6. The electrode device of  claim 1 , wherein the egress extends longitudinally through one end of the body. 
     
     
       7. The electrode device of  claim 1 , comprising a moisture sensor positioned within a non-conductive region of the body. 
     
     
       8. The electrode device of  claim 1 , wherein the egress has a longitudinal length to width aspect ratio within the range of 2:1 to 4:1. 
     
     
       9. The electrode device of  claim 1 , comprising two pair of activatable conductors. 
     
     
       10. The electrode device of  claim 9 , wherein each pair of activatable conductors comprises a cathode region and an anode region. 
     
     
       11. The electrode device of  claim 1 , wherein the body extends longitudinally through one of the first end or second end. 
     
     
       12. The electrode device of  claim 1 , wherein the egress is positioned between opposite lateral edges of the body. 
     
     
       13. The electrode device of  claim 1 , wherein the medial egress extends along a sagittal plane and at least one conductor is positioned on each side of the sagittal plane. 
     
     
       14. The electrode device of  claim 1 , wherein the medial egress defines an edge that resists flow of bodily fluid. 
     
     
       15. The electrode device of  claim 1 , wherein the outer periphery of the egress comprises a gasket to assist in resisting flow of bodily fluid passing through the egress. 
     
     
       16. The electrode device of  claim 1 , wherein a first of the at least two conductors is spaced from a second of the at least two conductors with the egress intermediate the first and second of the at least two conductors. 
     
     
       17. An electrode device for use in treating incontinence in an individual or animal, comprising:
 a body extending longitudinally between a posterior end and an anterior end, the body defining an outer peripheral edge having a generally hourglass shape wherein the lateral width narrows between the posterior end and anterior end, the body having a contact side and a non-contact side and defining a medial egress from the contact side to the non-contact side; 
 at least one activatable anterior conductor positioned on the contact side of the body proximate the anterior end substantially electrically insulated from the non-contact side; 
 at least one activatable posterior conductor positioned on the contact side of the body proximate the posterior end being substantially electrically insulated from the non-contact side and at least one anterior conductor, wherein 
 at least one anterior conductor and at least one posterior conductor are spaced from each other and positioned around the periphery of the egress, the contact side defines a surface and the hourglass peripheral shape allows for interfacing of the contact side surface with perineal tissue in a position with the medial egress aligned and external to a ureteral or vaginal opening in the individual or animal with the at least one posterior conductor in electrical communication with the at least one anterior conductor, whereby an electrical current generated between the conductors penetrates the perineal tissue to stimulate at least one muscle therein and bodily waste is allowed to be excreted freely from the ureteral or vaginal opening through the egress. 
 
     
     
       18. The electrode device of  claim 17 , comprising at least one insulated region in the contact side of the body positioned intermediate the medial egress and each of the anterior and posterior conductors. 
     
     
       19. The electrode device of  claim 17 , wherein the at least one posterior conductor and at least one anterior conductor each has a portion that is co-located with one another to provide electrical continuity to a common electrical connector.